
System Validation Specialist
4 days ago
About the Job:
We are seeking a highly experienced Validation Professional with a strong background in Computer System Validation and Quality Compliance in a regulated industry.
- Job Overview:
- You will be responsible for ensuring the quality and compliance of our systems and processes.
Key Responsibilities:
The ideal candidate will have 5-8 years hands-on experience in Computer System Validation/Quality Compliance in a regulated industry (Medical Device/Pharma/Life Sciences) with a focus on GxP system.
- Experience:
- A strong knowledge of fundamental cGMP concepts, FDA/EMA regulations, QSR, 21 CFR Part 820, 21 CFR Part 11, and ISO 9001 Standards is required.
Skills and Qualifications:
The successful candidate will have a strong knowledge of FDA Regulated manufacturing processes, process validation, computer and equipment validation, and GMPs.
- Knowledge:
- Hands-on experience in EDMS (Electronic Document Management system) & Test Management tools.
Requirements:
- Ability:
- Develop clear, concise, and timely oral and written reports.
- Excellent written and oral communication skills.
- Work on complex projects with general direction and minimal guidance.
- Manage multiple projects and meet deadlines.
- Manage priorities and workflow effectively.
What We Offer:
- Benefits:
- A dynamic work environment with opportunities for professional growth.
Note:
- Please only apply if you meet the requirements.
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